510(k) Report

510(k) · Cleared

Cleared

Polaris

K950388510(k) TraditionalCleared May 2, 199590-day reviewClass II21 CFR 868.1400

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spegas Industries, Ltd. · CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase

Cleared on May 2, 1995 after a 90-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 1 of the 322 devices in its family, counting itself, has a Class I recall. 321 later devices descend from it.

Decided
May 2, 1995
Review
90 days
Class
Class II
Product code
CCK
Recalls
None
Predicates
0

321 later devices descend from it, 1 citing it directly. 1 of the 322 devices in this family, counting this one, has a Class I recall.

Descendants, by year cleared 2004: 1 descendant cleared2006: 4 descendants cleared2005: 2 descendants cleared2007: 3 descendants cleared2009: 8 descendants cleared2016: 14 descendants cleared2010: 8 descendants cleared2012: 17 descendants cleared2015: 17 descendants cleared2014: 21 descendants cleared, 1 with a Class I recall12011: 8 descendants cleared2008: 2 descendants cleared2020: 20 descendants cleared2013: 17 descendants cleared2018: 16 descendants cleared2025: 20 descendants cleared2026: 18 descendants cleared2022: 27 descendants cleared2021: 16 descendants cleared2017: 20 descendants cleared2019: 19 descendants cleared2023: 22 descendants cleared2024: 21 descendants cleared1995200020052010201520202025
  1. This deviceK950388 PolarisSpegas Industries, Ltd. · 1995
  2. Descendant · cites it directly · 320 of its ownK040011 Polaris 2004 CapnographOridion, Ltd. · 2004
  3. Descendant · 2 generations on · 264 of its ownK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
  4. Descendant · 2 generations on · 250 of its ownK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
  5. Descendant · 3 generations on · 197 of its ownK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
  6. Descendant · 4 generations on · 170 of its ownK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled

Showing 5 of 321 descendants. See all descendants

Descendants cleared per year

2004: 12005: 22006: 42007: 32008: 22009: 82010: 82011: 82012: 172013: 172014: 212015: 172016: 142017: 202018: 162019: 192020: 202021: 162022: 272023: 222024: 212025: 202026: 18
2004high 27 (2022) · low 1 (2004)2026

Class I recalls in this family

  • K123690 CAPNOSTREAM20P with Hifi C02 Monitoring8 generations on · 2014

Most influential descendants

Showing 5 of 321 · See all
  • K040011Polaris 2004 CapnographOridion, Ltd. · 2004 · cites it directly320descendants
  • K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS…Cas Medical Systems, Inc. · 2005 · 2 generations on264descendants
  • K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside MonitorOridion Capnography, Inc. · 2006 · 2 generations on250descendants
  • K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007 · 3 generations on197descendants
  • K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · 4 generations on170descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950388PolarisSpegas Industries, Ltd.1995—
+1K040011Polaris 2004 CapnographOridion, Ltd.2004—
+2K050844750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…Cas Medical Systems, Inc.2005—
+2K060065CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…Oridion Capnography, Inc.20063
+3K072295Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc.2007—
+4K082268CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc.20099

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200520
200640
200730
200820
200980
201080
201180
2012170
2013170
2014211
2015170
2016140
2017200
2018160
2019190
2020200
2021160
2022270
2023220
2024210
2025200
2026180
FIG. 1 — Lineage of K950388, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new CCK device

  1. #1 K253030 Capnostream™35 Portable Respiratory Monitor…score 15.8 · 16 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (321)

See all 321

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K040011Polaris 2004 CapnographOridion, Ltd.2004320

Has anything in its family been recalled? (1 Class I)

No FDA recall names this device.

Relatives with a Class I recall

Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.

  • K123690CAPNOSTREAM20P with Hifi C02 MonitoringOridion Medical 1987, Ltd. · 2014 · 8 generations on · ◆ in the 2014 descendants bar of FIG. 11 Class I recall

What does this lineage say?

  • Of its descendants, K040011 (Oridion, Ltd., 2004) has gone furthest, with 320 descendants of its own.

How does its category compare?

All CCK devices

CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · CCK

3in 2025

2007: 52008: 32009: 32010: 32011: 22012: 72013: 42014: 92015: 52016: 22017: 52018: 62019: 72020: 42021: 42022: 32023: 42024: 32025: 32026 (partial year): 3
2007high 9 (2014) · low 2 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · CCK

169in 2025

2007: 56 days median2008: 248 days median2009: 101 days median2010: 125 days median2012: 150 days median2013: 132 days median2014: 166 days median2015: 105 days median2017: 134 days median2018: 296 days median2019: 261 days median2020: 188 days median2021: 227 days median2022: 226 days median2023: 555 days median2024: 592 days median2025: 169 days median2026 (partial year): 224 days median
2007high 592 (2024) · low 56 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · CCK

1in 2022

2008: 12009: 192010: 42011: 142012: 32013: 2, 1 Class I2015: 12018: 52019: 7, 7 Class I2020: 12022: 1
2007high 19 (2009) · low 0 (2007)2026

Class I (8 since 2007) Class II/III not classified

Adverse event reports per year · CCK

1,259in 2025

2007: 72008: 202009: 212010: 122011: 182012: 132013: 282014: 512015: 1142016: 882017: 582018: 632019: 1412020: 2,3022021: 2,2722022: 2,4752023: 1,6372024: 1,2162025: 1,259
2007high 2,475 (2022) · low 7 (2007)2025

MAUDE reports naming product code CCK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200755607
20083248120
200931011921
20103125412
20112—1418
20127150313
201341322 (1)28
20149166051
201551051114
20162—088
20175134058
20186296563
201972617 (7)141
2020418812,302
2021422702,272
2022322612,475
2023455501,637
2024359201,216
2025316901,259
202632240—

More from Spegas Industries, Ltd.

5 FDA decisions under this applicant name. See the company

  • K964239Combination Oximeter/Carbon Dioxide Gas AnalyzerSpegas Industries, Ltd. · 1997
  • K950387GeminiSpegas Industries, Ltd. · 1995
  • K942849CapnosatSpegas Industries, Ltd. · 1995
  • K933707CapnodigSpegas Industries, Ltd. · 1993

Recent decisions in CCK

The CCK category page

  • K251641GF-310R Multigas Unit (GF-310R)Nihon Kohden Corporation · 2026
  • K261633VisuBreathAffirm Medical Technologies II, LLC · 2026
  • K253030Capnostream™35 Portable Respiratory Monitor (PM35MN)Covidien, LLC · 2026
  • K250148Medical Gas Analyzer (AG200)Prior Care Science Technology, Ltd. · 2025
  • K243956TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)Nihon Kohden Corporation · 2025

https://510kreport.com/device/K950388 · printed Nov 6, 2026

Cite this page

510(k) Report. “K950388: Polaris.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K950388

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026